Senators to FDA: "Please Explain" Why the Hell You Stymied EpiPen Competition! | Pharma Industry Regulation |

While anger is directed at Mylan Pharmaceuticals over the rising cost of its EpiPen device, some lawmakers wonder whether the US Food and Drug Administration … made it possible for Mylan to dominate the market and charge whatever price it wants.


Specifically, five US senators wrote the FDA Thursday to express concerns the agency may have helped stifle competition. And in their letter to FDA Commissioner Dr. Robert Califf, the lawmakers worry the FDA is not doing enough to ensure that competitive versions are available, especially given that epinephrine — the main ingredient in EpiPen — has been on a drug shortage list since 2012.


The letter was sent by Senator Chuck Grassley (R-Iowa); Senator Amy Klobuchar (D-Minn.); Senator Richard Blumenthal (D-Conn.); Senator Patrick Leahy (D-Vt.); and Senator Ron Johnson (R-Wis.).


The issue is being raised largely in response to recent developments. Last year, Sanofi withdrew a rival product called Auvi-Q, which was introduced in 2013, after 26 cases in which the device delivered an inaccurate dose. Earlier this year, the FDA rejected a generic EpiPen developed by Teva Pharmaceuticals and then required Adamis to expand studies for its own device.